The safety and tolerability of alkaloids from Alstonia scholaris leaves in healthy Chinese volunteers: a single-centre, randomized, double-blind, placebo-controlled phase I clinical trial

doi:10.1080/13880209.2021.1893349

KIB OpenIR

	The safety and tolerability of alkaloids from Alstonia scholaris leaves in healthy Chinese volunteers: a single-centre, randomized, double-blind, placebo-controlled phase I clinical trial
	Gou,Zhong-Ping ; Zhao,Yun-Li ; Zou,Lin-Ling ; Wang,Ying ; Shu,Shi-Qing ; Zhu,Xiao-Hong ; Zheng,Li ; Shen,Qi ; Luo,Zhu ; Miao,Jia ; Wang,Yong-Sheng ; Luo,Xiao-Dong; Feng,Ping
	2021
发表期刊	PHARMACEUTICAL BIOLOGY
ISSN	1388-0209
卷号	59 期号:1 页码:484-493
摘要	ContextCapsule of alkaloids from the leaf of Alstonia scholaris (L.) R.Br. (Apocynaceae) (CALAS) is a new investigational botanical drug (No. 2011L01436) for bronchitis, post-infectious cough and asthma.ObjectiveTo observe the clinical safety and tolerability of CALAS.Materials and methodsSubjects were assigned to eight cohorts, and each received randomly CALAS or placebo in one of single ascending dose (SAD) of 8, 40, 120, 240, 360, 480, or in one of multiple ascending dose (MAD) of 40 or 120 mg, three times daily for 7 days. Each cohort contained two placebo subjects.ResultsSixty-two enrolled volunteers completed the study and no serious adverse events and clinically significant changes in vital signs, electrocardiography, and upper abdominal Doppler ultrasonography were observed. The ratios of treatment-emergent adverse events (TEAEs) were reported in 11/46 (23.91%) of CALAS groups and 3/16 (18.75%) of the placebo group (p > 0.05), respectively, based on the results of SAD and MAD. All TEAEs were mild, transient, and disappeared without any intervention. The TEAEs possibly related to CALAS treatment were as followings: hiccups (4/46: 8%), dry mouth and nausea (3/46: 6%), increased sleep (2/46: 4%), abdominal distension (1/46: 2%), bilirubin elevated (1/46: 2%).Discussion and conclusionsCALAS is safe and well-tolerated with no unexpected or clinically relevant safety concerns up to a single dose of 360 mg and three times daily for 7 days up to 120 mg in healthy Chinese volunteers, supporting further Phase II studies.
关键词	Clinical safety healthy subject dose-escalation study MONOTERPENOID INDOLE ALKALOIDS FLIGHT MASS-SPECTROMETRY EXTRACT IDENTIFICATION CONSTITUENTS
DOI	10.1080/13880209.2021.1893349
WOS记录号	WOS:000644568700001
引用统计
文献类型	期刊论文
条目标识符	http://ir.kib.ac.cn/handle/151853/73694
专题	中国科学院昆明植物研究所
作者单位	1.[Gou, Zhong-Ping 2.Zou, Lin-Ling 3.Wang, Ying 4.Shu, Shi-Qing 5.Zhu, Xiao-Hong 6.Zheng, Li 7.Shen, Qi 8.Luo, Zhu 9.Miao, Jia 10.Wang, Yong-Sheng 11.Sichuan Univ, West China Hosp, Inst Drug Clin Trials, Chengdu 610041, Peoples R China 12.[Zhao, Yun-Li 13.Chinese Acad Sci, Kunming Inst Bot, State Key Lab Phytochem & Plant Resources West Ch, Kunming 650201, Yunnan, Peoples R China 14.Yunnan Univ, Minist Educ, Key Lab Med Chem Nat Resource, Kunming, Yunnan, Peoples R China 15.Yunnan Univ, Yunnan Prov Ctr Res & Dev Nat Prod, Kunming, Yunnan, Peoples R China 16.Yunnan Univ, Sch Chem Sci & Technol, Kunming 650091, Yunnan, Peoples R China
推荐引用方式 GB/T 7714	Gou,Zhong-Ping,Zhao,Yun-Li,Zou,Lin-Ling,et al. The safety and tolerability of alkaloids from Alstonia scholaris leaves in healthy Chinese volunteers: a single-centre, randomized, double-blind, placebo-controlled phase I clinical trial[J]. PHARMACEUTICAL BIOLOGY,2021,59(1):484-493.
APA	Gou,Zhong-Ping.,Zhao,Yun-Li.,Zou,Lin-Ling.,Wang,Ying.,Shu,Shi-Qing.,...&Feng,Ping.(2021).The safety and tolerability of alkaloids from Alstonia scholaris leaves in healthy Chinese volunteers: a single-centre, randomized, double-blind, placebo-controlled phase I clinical trial.PHARMACEUTICAL BIOLOGY,59(1),484-493.
MLA	Gou,Zhong-Ping,et al."The safety and tolerability of alkaloids from Alstonia scholaris leaves in healthy Chinese volunteers: a single-centre, randomized, double-blind, placebo-controlled phase I clinical trial".PHARMACEUTICAL BIOLOGY 59.1(2021):484-493.